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A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer


OBJECTIVES:

- Compare the effectiveness, in terms of overall survival, of consolidation therapy with
or without strontium chloride Sr 89 after induction chemotherapy in patients with
androgen-independent prostate cancer.

OUTLINE: This is a randomized study. Patients are stratified according to type of induction
chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20
vs more than 20), ECOG performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).

- Induction therapy: Patients receive 1 of 2 induction therapy regimens.

- Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral
ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive
vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on
days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8.
Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease
progression or unacceptable toxicity.

NOTE: *Patients continue to receive oral ketoconazole three times daily until disease
progression.

- Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on
days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment
repeats every 21 days for at least 5 courses in the absence of disease progression or
unacceptable toxicity.

- Consolidation therapy: Patients with a prostate-specific antigen (PSA) response
(at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA
levels decreased at least 50% from baseline) are randomized to 1 of 2
consolidation treatment arms.

- Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus
strontium chloride Sr 89 IV once at the beginning of chemotherapy.

- Arm II: Patients receive doxorubicin as in arm I. Patients are followed every 4 weeks
until PSA progression and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this
study within 48 months.


Inclusion Criteria:



1. Rising PSA on at least 2 occasions >1 week apart (minimum value of 5 ng/ml),
accompanied either by bone pain or, if the patient is asymptomatic, by a worsening
bone scan with new lesions over a period of <6 months

2. Patients on antiandrogens should be discontinued from flutamide or nilutamide for at
least 4 weeks and bicalutamide for 6 weeks; If progression is documented during this
time interval as in inclusion criterion # 1, patients are eligible

3. Osteoblastic metastases on bone scan or CT scan

4. Androgen-independent prostate adenocarcinoma

5. Castrate testosterone level testosterone must be continued

6. >/= 18 years of age

7. Life expectancy of greater than or equal to 12 weeks

8. Zubrod performance status
9. Patients must have normal organ and marrow function as defined below: Leukocytes
greater than 3,000/mcL Absolute neutrophil count greater than 1,500/mcL Platelets
greater than 100,000/mcL Total bilirubin less than or equal to 2X institutional upper
limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2X institutional upper
limit of normal

10. The patient must have the ability to understand and the willingness to sign a written
informed consent document

11. Participating subjects and their female partners agree to the use of adequate
contraception (hormonal or barrier method of birth control) prior to study entry and
for the duration of study participation

Exclusion Criteria:

1. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the agents used on this trial

2. Prior doxorubicin, or vinblastine in the KAVE arm and prior docetaxel in the
prednisone plus docetaxel arm. However, previous treatment using other secondary
hormonal agents (aminoglutethimide, diethylstilbesterol, estramustine), steroids
(dexamethasone, prednisone, hydrocortisone), angiogenesis inhibitors, gene therapy,
or immunotherapy are allowed

3. More than one prior cytotoxic treatment

4. Prior Sr-89 or Sm-153 treatment

5. Patients who have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6
weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
not recovered from adverse events due to agents administered more than 4 weeks
earlier

6. Previous vagotomy or other conditions (such as pernicious anemia) associated with
achlorhydria. Patients with active peptic ulcer disease who still require regular use
of H2 blockers (such as cimetidine [Tagamet], ranitidine [Zantac], famotidine
[Pepcid], etc), proton pump inhibitors (omeprazole [Prilosec]), or antacids (Mylanta,
Maalox, Tums, etc) at week 16 of induction chemotherapy (option 1 only) might not be
suitable for randomization

7. Predominant visceral metastases in the liver, lungs, or brain

8. Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive
disease (hematuria)

9. Small cell carcinoma

10. Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI)
within 12 months, or active angina or claudication sufficient to limit activity

11. Active or likely to become active second malignancy (other than non-melanoma skin
cancer)

12. Uncontrolled inter-current illness: including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Followed every 4 weeks until PSA progression then every 3 months

Safety Issue:

No

Principal Investigator

Shi-Ming Tu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID00-156

NCT ID:

NCT00024167

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Strontium-89
  • Induction Chemotherapy
  • Androgen-Independent Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Medical City Dallas HospitalDallas, Texas  75230
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - GreenvilleGreenville, South Carolina  29615
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Treatment CenterWooster, Ohio  44691
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Kinston Medical SpecialistsKinston, North Carolina  28501
McLeod Regional Medical CenterFlorence, South Carolina  29501
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Cancer Care Center, IncorporatedSalem, Ohio  44460